"We were waiting for our first child to arrive,” says Ravi Nayak, a 25-year-old mason in Kota, Rajasthan, his voice trailing off in anguish. When his wife Jyoti Verma developed labour pains on May 4, he rushed her to the Government Medical College. The next day, the 20-year-old underwent a caesarean section and delivered a healthy baby boy. Mother and child were fine, Nayak sighed with relief.Doctors prescribed oxytocin for Verma shortly after delivery. An injection of synthetic oxytocin is widely used in childbirth to induce labour as well as to prevent and treat postpartum haemorrhage.But that shot allegedly changed everything for the young woman. Within hours, recalls Nayak, his wife’s blood pressure sank. As he screamed for help, her vitals showed distress signals. Soon her kidneys began to fail, forcing doctors to opt for an emergency dialysis. They placed a temporary catheter in her jugular vein for haemodialysis. All the efforts were in vain. A profusely bleeding Verma passed away on May 7, just two days after giving birth, leaving behind a newborn that will never know his mother.“Mere paas toh nishani chhod gayi hai (She went, leaving behind the child),” says Nayak, as his mother gives the two-month-old baby powdered milk. He mumbles, “Maa toh maa hoti hai. Itna mushkil ho raha hai bachche ke liye (Mother cannot be replaced. It’s been so hard on the child).”Verma’s postmortem report offers no clear answers to her death. A terse line says, “Pending till receipt of histopathology report and detailed treatment record made available.” Her death remains officially undetermined.But it was not just Verma. Four other young women died in hospitals in Kota after delivery through C-section Payal Malviya, 27; Priya Mahavar, Pinki Mahavar and Shireen, all 20.Priya died in JK Lon Mother and Child Hospital and all the others in the Government Medical College.Priya died within hours of being shifted to the general ward, says her husband Rohit. He recalls that an injection was administered to her. In a few minutes, he says, she turned black and her pulse stopped.Also read | Fear and doubts post E20 rollout produce an unlikely winnerRohit travels every day from his home in Bundi to work in Kota and makes just about Rs 8,000 a month. He is torn between grief, backbreaking work and the responsibility of bringing up a baby alone.All the five women who died in a span of 12 days between May 5 and 17 in Kota belonged to families of daily wagers who do not know whom to sue and how to demand justice.Eight other women who reportedly received oxytocin are undergoing treatment at the super speciality wing of the Medical College for complications and fighting for their lives.Highlighted portions of Punjab FDA’s report on Jackson LaboratoriesOXY TOXIN?Dr Nilesh Jain, principal of Kota Medical College and medical director, says an inquiry report prepared by an expert committee from AIIMS–Delhi found no evidence of “human error” in the deaths. The committee’s findings indicate that the deaths resulted from multiple contributing factors rather than any single lapse or act of negligence by the hospital staff.The needle of suspicion pointed to the oxytocin injection that was administered to all these women. Inspectors of Rajasthan’s Food Safety and Drug Control Commissionerate sent oxytocin samples from the Kota hospitals to a state government laboratory. On May 25, the state’s drugs controller issued an alert: the oxytocin samples did not contain the active ingredient, oxytocin. The vials just had water. The batch was tested and found “Not of Standard Quality”. “The vials were labelled as a life-saving drug. They contained none of the active ingredient meant to be in them,” the report says.Also read | Indian travellers change direction, give West a missAccording to the Drugs and Cosmetics Act, a drug is called spurious if it does not have the active ingredient it claims to contain and has been substituted wholly or in part by another substance.The deaths of five young mothers in Rajasthan have now widened into a probe into a Punjab-based company that manufactured the oxytocin injections used in the Kota hospitals Jackson Laboratories.At the centre of the investigation is its brand called Tocin, Batch No. I-7881.Soon after the alert by the Rajasthan authorities, a six-member joint inspection team from the Punjab Food and Drugs Administration (FDA) and the Central Drugs Standard Control Organisation (CDSCO) descended on Jackson Laboratories’ facility in Amritsar. They reportedly found end-to-end manufacturing lapses, failure in quality control and deliberate falsification of records.On June 3, the Punjab FDA cancelled the manufacturing licence of Jackson Laboratories’ Amritsar unit. On June 23, the licence of its unit in Baddi, Himachal Pradesh, was also cancelled with immediate effect. According to documents accessed by ET, both sites have been slammed by state regulatory agencies for a pattern of sustained, unchecked manufacturing violations.Jackson Laboratories has not responded to queries from ET. However, according to media reports, it has approached the court challenging the findings of the lab and the regulatory authorities and contesting the discrepancies cited against it.Meanwhile, Rajasthan authorities have sent samples from the implicated batch to a lab in Kolkata for independent testing.Amulya Nidhi, national convenor of the public health advocacy group Jan Swasthya Abhiyan India, says the charges of spurious oxytocin are alarming. He says: “This points to a serious failure of drug regulation and public health governance. The cancellation of the manufacturer’s licence must be followed by a transparent investigation and strict action against all those who are responsible.” He has urged the government to strengthen drug quality surveillance, ensure accountability and prevent such avoidable tragedies from recurring again.THE INVESTIGATIONThe probe of the Punjab FDA and CDSCO into Jackson Laboratories began with a review of control samples from 80 ampoules in two boxes of 40 each. They reportedly found worrying discrepancies. The two boxes allegedly had conflicting packaging information like different storage instructions although they contained the same batch of the same drug, raising questions about the product being sold.The investigating team found other incongruities as well. According to Jackson Laboratories’ Certificate of Analysis, the batch was tested and released on December 8, 2025. However, the company’s own quality control register reportedly showed that the sample was received in the lab nine days later on December 17.There was more. The firm’s certificate said a high-performance liquid chromatography machine was used for testing and analysis. However, there was reportedly no record of such a test in the machine’s software. Investigators, instead, found the test was conducted in a different machine one that had been installed just days before testing began. It had never been calibrated and showed signs of a deliberately altered audit trail dates were changed, entries were deleted and the system was reportedly configured “to avoid the traceability of activities performed on the instrument”, according to documents seen by ET.Investigators also found that wrong equipment and standards were used for lab tests which could compromise results a 150 mm chromatography column (a cylindrical tube) was used instead of the required 100 mm, according to Indian Pharmacopoeia rules. Also, the company’s own paperwork says it injected 100 microlitres of the sample during testing, instead of the prescribed 100 picolitres. A microlitre is a million times bigger than a picolitre. Investigators suspect that either the test was not conducted properly or that the records were mindlessly copied, raising questions about data integrity. They reportedly could not find any reference standard for oxytocin nor any data for the mandatory vasopressin impurity test.The purchase records of the active pharmaceutical ingredient (API) were also reportedly sketchy. Sixty litres of oxytocin API (Batch PS-321951) were purchased from Mumbai-based Hemmo Pharmaceuticals on June 2, 2025. However, investigators found no raw data for the test that certified it. They say it was “fabricated/fake test data”. API requires cold storage but the inspectors reportedly found no temperature monitoring records.What’s more, when the inspectors went into the quality control lab, they allegedly saw an operator copying entries from old log books into new ones. Quality assurance did not have any oversight of log books, which had no issuance register or controlling signatures, pointing to possible data manipulation, the report says.The inspection report concludes that “a strong possibility for any changes and manipulations cannot be ruled out”, rendering the firm’s manufacturing, quality control, stores and microbiology records “in question and cannot be trusted/relied upon”. Investigators say they could not even confirm that the API had been properly weighed and dispensed into the batch. The issuance slip was reportedly missing weights, dates, time and signatures entirely.HISTORY OF VIOLATIONSIf anything can be more concerning, it is that this is not the first time Jackson Laboratories has been hauled up for manufacturing substandard drugs and ordered to stop production.Government records seen by ET show the company has a history of serious violations and data fabrication. Worse, despite regulatory actions, the management of Jackson Laboratories allegedly paid no heed to orders for a complete halt of production.It began three years ago. A joint inspection team of CDSCO and Punjab FDA audited its Amritsar facility and found it to be “grossly deficient in compliance with GMP (good manufacturing practices) and GLP (good laboratory practices) norms”. It was reportedly found to be in violation of Schedule M (Part 1A), Schedule U and Rules 74 and 78 of the Drugs Rules, 1945 which cover manufacturing standards, protocols for keeping records and conditions for drugmanufacturing licences.In March 2023, a show-cause notice was served along with a “stop production” order. The firm was asked to immediately halt the manufacturing of small volume parenterals or sterile injections, external preparations and beta-lactam antibiotics, sex hormones, steroid tablets and capsules. Jackson Laboratories did not appeal against that order. Instead, the company allegedly chose to disregard it and continue production from the same facility.Soon, in August 2023, AIIMS–Jodhpur complained that Jackson Laboratories’ caffeine citrate injection (used in neonatal intensive care units) had caused infections in newborns. A sample was tested and reportedly “declared as grossly sub-standard with respect to BET (bacterial endotoxin tests) and sterility parameters”.A further inspection by state agencies in August 23-25, 2023, reportedly uncovered serious GMP violations, including unclassified manufacturing areas, lack of environmental monitoring and poor aseptic practices. An interim stop-manufacturing order was passed for its sterile injections. A final order came on October 13, 2023. The company was ordered not to conduct any manufacturing activity. Otherwise, they would cancel its drug manufacturing licence or initiate legal action against it.The company, according to Punjab FDA, did not take any steps to rectify the shortcomings observed by the regulatory authorities.Jackson’s Baddi unit in Himachal Pradesh was allegedly no different. An inspection in August 2023 revealed that 3 out of 11 drugs tested were grossly substandard.The same irregularities were reportedly found in 2024 and 2025. An inspection of the liquid oral drugs and cough syrup section in December 2025 allegedly found that its renovation work was incomplete and the HVAC (heating, ventilation and air conditioning) system non-compliant. Production in that section was ordered to be halted in January this year.A compliance report submitted by the firm later that month was found to be inadequate by CDSCO’s Baddi unit in March 2026, which asked for a detailed, point-by-point documentation.Five young women have paid with their lives for a vial of allegedly spurious drug and lax enforcement even after authorities repeatedly investigated into and flagged critical flaws in a drug-manufacturing company.“For most drug manufacturing units, the state is the licensing authority—the onus of monitoring, inspection and enforcement lies entirely with them. The question of how production continued despite stop orders is one that the state licensing authority must answer,” says a drug regulatory official.NOT THE FIRST TIMEIn India, spurious and contaminated drugs have played havoc with public health, time and again, and resulted in tragic fatalities.In 2024, five women who had C-section died of multiple organ failure in Ballari, Karnataka, after they were administered a contaminated solution of Ringer’s lactate.Just last year, spurious cough syrups laced with a toxic industrial chemical killed nearly two dozen children in Madhya Pradesh. Similar incidents were also reported in African nations, raising concerns worldwide over the quality of drugs made in India.TINY MARKETWhen it comes to oxytocin, the Indian market is valued at just Rs 42 crore, according to market research firm PharmaTrac. It is an alarmingly small market for a drug that is administered to nearly every woman who delivers in a hospital across the country. The organised, branded generic segment is dominated by a handful of companies: Pfizer, Viatris, Neon Laboratories, Maneesh Pharmaceuticals and Karnataka Antibiotics and Pharmaceuticals Limited. Several other manufacturers—Zydus, Mercury Healthcare, Laborate, Themis and Torque —have reduced their production of oxytocin or exited the segment entirely, shrinking the pool of large, traceable producers.The dwindling of the formal market, say industry insiders, has opened up space for a parallel and opaque supply chain to take root. “There are many players in the grey or under-the-radar market,” says an industry insider familiar with the sector. “In places like Gaya in Bihar, oxytocin is manufactured in small factories that follow no standards and are completely unregulated,” alleges the insider, pointing to firms that work under little to no oversight and distribute drugs through channels that rarely find mention in official data or inspection schedules until something goes catastrophically wrong.What are the consequences of such catastrophes? According to Section 27A of the Drugs and Cosmetics Act, if a spurious drug causes death, the punishment is 10 years’ imprisonment, extendable to life, plus a fine of not less than `10 lakh or three times the value of drugs seized, whichever is greater.Meanwhile, back in Kota, Ravi Nayak, who is mourning the death of his wife, says he has not got a single call from the authorities, either to condole or to talk about compensation.“Our entire world has been destroyed. But till today, not a single phone call has come from the administration. We have lost trust in everyone now,” he says. “We should at least get compensation. Don’t we have that much right? We may be poor but we are human beings.”Things to knowAccording to the Drugs and Cosmetics Act, a drug is called spurious if it does not have the active ingredient it claims to contain, and is substituted wholly or in part by another substance.Needle of suspicion pointed to oxytocin injections given to the women. On May 25, Rajasthan drugs controller issued an alert: the oxytocin samples did not contain oxytocin. The vials just had water.The vials were manufactured by Jackson Laboratories based in Amritsar. The company has refuted the report.Inspectors of Punjab FDA & CDSCO visited its factory, reported multiple violations .They found that test records certifying the oxytocin vials were fabricated and the equipment was uncalibrated .Jackson Laboratories is under a Stop Production Order from Punjab FDA since 2023.A probe of Punjab FDA and CDSCO into Jackson Laboratories’ Amritsar facility found many discrepancies. They also flagged that drugmaker has a history of violations and data fabrication. In August 2023, AIIMS-Jodhpur complained that Jackson Laboratories’ caffeine citrate injection (used in neonatal intensive care units) had caused infections in newborns. In October 13, 2023, the company was ordered not to conduct any manufacturing activity. An inspection of Jackson’s Baddi unit in HP in August 2023 also reportedly revealed that 3 out of 11 drugs tested were grossly substandard.What is Oxytocin?An injection of synthetic oxytocin is widely used in childbirth to induce labour as well as to prevent and treat postpartum haemorrhage. It is given to virtually every woman who delivers in a hospital.